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Screw Driver for Machine
EUDAMEDClass IIa (EU MDR)
Ref HBDM123MModel IH IMPLANT SYSTEM Ref MHD125MRef HBDM123LRef MSD120SRef HBDM128MRef MHD125LRef MHD125SRef MSD120LRef MHD120SRef MHD128LRef SBDM120MRef HBDM128SRef MHD128MRef MHD128SRef MHD123M
Identity
- Trade Name
- Screw Driver for Machine EUDAMED
- Device Name
- Screw Driver for Machine EUDAMED
- Model / Reference
- IH IMPLANT SYSTEM EUDAMEDHBDM123M EUDAMEDMHD125M EUDAMEDHBDM123L EUDAMEDMSD120S EUDAMEDHBDM128M EUDAMEDMHD125L EUDAMEDMHD125S EUDAMEDMSD120L EUDAMEDMHD120S EUDAMEDMHD128L EUDAMEDSBDM120M EUDAMEDHBDM128S EUDAMEDMHD128M EUDAMEDMHD128S EUDAMEDMHD123M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800041362592 EUDAMED08800041362295 EUDAMED08800041362585 EUDAMED08800041362370 EUDAMED08800041362653 EUDAMED08800041362288 EUDAMED08800041362301 EUDAMED08800041362394 EUDAMED08800041362240 EUDAMED08800041362318 EUDAMED08800041362684 EUDAMED08800041362660 EUDAMED08800041362325 EUDAMED08800041362332 EUDAMED08800041362264 EUDAMED
- Basic UDI-DI
- B-08800041362592 EUDAMEDB-08800041362295 EUDAMEDB-08800041362585 EUDAMEDB-08800041362370 EUDAMEDB-08800041362653 EUDAMEDB-08800041362288 EUDAMEDB-08800041362301 EUDAMEDB-08800041362394 EUDAMEDB-08800041362240 EUDAMEDB-08800041362318 EUDAMEDB-08800041362684 EUDAMEDB-08800041362660 EUDAMEDB-08800041362325 EUDAMEDB-08800041362332 EUDAMEDB-08800041362264 EUDAMED
- EMDN Code
- L159016 DENTAL SURGERY INSTRUMENT KITS, REUSABLE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Screw Driver for Machine by SEWONMEDIX Inc. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Dental/maxillofacial surgical procedure kit, non-medicated, reusable.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800041362592 | Class IIa | Active |
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Manufacturer
- Manufacturer
- SEWONMEDIX Inc.
- EUDAMED SRN
- KR-MF-000016194
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (15)
- EUDAMED d067fd5e-0645-4d9b-a9cc-848365baa022 61 fields · synced Aug 4, 2026
- EUDAMED 91d32523-cf33-46c8-8faf-3b5e687e16a0 61 fields · synced May 16, 2026
- EUDAMED 3c8526a3-5cc0-4833-af7a-7e800317f428 61 fields · synced May 17, 2026
- EUDAMED a81e2ede-d44d-4c1d-8fe2-af361af58a29 61 fields · synced May 17, 2026
- EUDAMED 3abba57a-e90c-464e-9d9d-a823df2a8b47 61 fields · synced May 17, 2026
- EUDAMED e4807ba8-95f7-42ac-b242-a9a78abe82ee 61 fields · synced May 18, 2026
- EUDAMED 9469fb74-3b57-43f2-9339-b176ac95a117 61 fields · synced May 18, 2026
- EUDAMED 1e4e77e3-2281-4ab2-9b44-71f955c72cb5 61 fields · synced May 18, 2026
- EUDAMED ecff9896-7add-4a88-aaa2-edf82a044e33 61 fields · synced May 18, 2026
- EUDAMED 3b15b097-ac6c-4abe-9081-38aab25ff1c4 61 fields · synced May 18, 2026
- EUDAMED 1137cc74-f526-4427-b736-fae559ad3936 61 fields · synced May 18, 2026
- EUDAMED 859b0d6b-5c61-48d0-9ddc-03aee1aaab8a 61 fields · synced May 18, 2026
- EUDAMED 401125ee-ffc0-4ace-b697-80e900aa58b5 61 fields · synced May 18, 2026
- EUDAMED fa17944e-163a-4443-bf49-3cca7bb642aa 61 fields · synced May 18, 2026
- EUDAMED f01bb604-6d6d-4940-8655-5355e59ff9ae 61 fields · synced May 18, 2026